Efficacy and Safety of Lenalidomide as a Treatment for Recurrent or Refractory POEMS Syndrome Trial

POEMS Syndrome Clinical Trial

Official title:

Single Arm Open-label Trial to Investigate the Efficacy and Safety of Lenlidomide as a Treatment for Recurrent or Refractory Crow-Fukase (POEMS) Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02193698
• Other study ID #: G26007
• Status: Completed
• Phase: Phase 2
• First received: July 16, 2014
• Last updated: July 27, 2016
• Start date: July 2014
• Est. completion date: April 2016

Study information

• Verified date: July 2016
• Source: Chiba University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study investigates the efficacy and safety of Lenalidomide as a treatment for recurrent or refractory POEMS (Crow-Fukase) syndrome.

Description:

This study investigates the efficacy and safety of Lenalidomide as a treatment for recurrent /refractory POEMS (Crow-Fukase) syndrome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: April 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Patients with Crow-Fukase syndrome (confirmed by diagnostic criteria.)

2. Recurrent or refractory Crow-Fukase syndrome.

3. Patients without severe liver or renal dysfunction.

4. Patients without severe neutropenia or thrombocytopenia.

5. Patients without clinically problematic ECG findings

6. Negative on the pregnacy test on the day 1 of cycle 1.

7. Patients who can undertake prevention of pregnancy, if necessary.

8. Patients with written informed consent.

9. Patients who are capable of ambulatory hospital visits every 4 weeks.

10. Patients with informed consent to the registration and rules of RevMate®.

Exclusion Criteria:

1. Patients who have been administered, bortezomib, lenalidomide, melpharan within 4 weeks prior to the registration.

2. Patients who have been on steroid treatment (more than 10mg/day in predonine) within 2 weeks prior to the registration.

3. Patients who have been administered bevacizumab within 12 weeks prior to the registration.

4. Patients who could worsen acutely during the clinical trial period.

5. Patients with severe complicaitons ( cardiac failure, renal failure liver failure, bleeding enterogastric ulcer, ileus, poorly controlled diabetes.

6. Patients with malignancies.

7. Female patients who are pregnant or desire childbearing. Males who desire fertility.

8. Patients who allergic to lenalidomide or dexamethasone.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• POEMS Syndrome
• Syndrome

Intervention

Drug:
• Lenalidomide+Dexamethasone
Lenalidomide 25mg/day (day 1-21) Dexamethasone 20mg/day (day 2. 9, 16, 23)

Locations

Country	Name	City	State
Japan	Chiba University Graduate School of Medicine Department of neurology	Chiba

Sponsors (1)

Lead Sponsor	Collaborator
Chiba University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction rate of serum VEGF		after 24 weeks	No